卡维地洛与食管静脉曲张套扎于静脉曲张出血的一级预防：

StephenW

Carvedilol versus Esophageal Variceal Band Ligation in the primary prophylaxis of variceal hemorrhage: A multicentre randomized controlled trial

    Hasnain Ali Shaha, Corresponding author contact information, E-mail the corresponding author,
    Zahid Azamb,
    Javeria Raufa,
    Shahab Abida,
    Saeed Hamida,
    Wasim Jafria,
    Abdullah Khalidb,
    Faisal Ismaila,
    Om Parkasha,
    Amna Subhana,
    Syed Mohammad Munirc

    a Section of Gastroenterology, Aga Khan University, Karachi, Pakistan
    b National Institute of Liver & GI Diseases, Dow University of Health Sciences, Karachi, Pakistan
    c Medical Unit VII, Jinnah Postgraduate Medical Centre, Karachi, Pakistan


Abstract
Background and aims

Esophageal variceal bleed is a major problem in patients with cirrhosis. Endoscopic variceal ligation (EVL) has been shown to be equal to or better than propranolol in preventing first bleed. Carvedilol is a non-selective ß-blocker with alpha-1 adrenergic blocker activity. Hemodynamic studies have shown Carvedilol to be more effective than propranolol at reducing portal pressure. We compared efficacy of carvedilol with EVL for primary prophylaxis of esophageal variceal bleed.
Methods

Cirrhotic patients with esophageal varices were randomized to carvedilol 12.5mg daily or EVL at three university hospitals of Pakistan. End points were esophageal variceal bleeding, death or liver transplant.
Results

Two hundred and nine patients were evaluated. Eighty two and 86 patients were randomized in carvedilol and EVL arms respectively. Mean age was 48±12.2 years; 122 (72.7%) were males; 89.9% had viral cirrhosis; mean Child-Pugh score was 7.3±1.6 and mean follow up was13.3±12.1 months (range 1-50 months). Both EVL and carvedilol groups had comparable variceal bleeding rates (8.5% vs. 6.9%), bleed related mortality (4.6% vs. 4.9%) and overall mortality (12.8% vs. 19.5%) respectively. Adverse events in carvedilol group were hypotension (n=2), requiring cessation of therapy, while transient nausea (n=18) and dyspnea (n=30) resolved spontaneously. In EVL arm, Post banding ulcer bleed (n=1) and chest pain (n=17), were termed as serious adverse eventswhile transient dysphagia (n=58) resolved without treatment.
Conclusion

Although our study is underpowered, the findings suggest that carvedilol is probably not superior to EVL in preventing first variceal bleed in patients with viral cirrhosis.
Abbreviations

    EVL, Esophageal Variceal Ligation;
    EVB, Esophageal variceal bleed;
    HCV, Hepatitis C Virus;
    HBV, Hepatitis B virus;
    HDV, Hepatitis Delta virus;
    PVT, Portal vein Thrombosis;
    HCC, Hepatocellular Carcinoma;
    GCP, Good Clinical Practice;
    E.R, Emergency Room;
    GV, Gastric varix;
    EV, Esophageal varix;
    EKG, Electrocardiogram;
    BCU, Bleeding Care Unit;
    Hb, Hemoglobin;
    ITT, Intention to treat;
    CI, Confidence Interval;
    IHD, Ischemic heart disease;
    HVPG, Hepatic venous pressure gradient;
    EGD, Esophago-gastro-duodenoscopy;
    TIPS, Transjugular intrahepatic portosystemic shunt;
    PSE, Porto-systemic encephalopathy

StephenW

卡维地洛与食管静脉曲张套扎于静脉曲张出血的一级预防：一项多中心随机对照试验

    HASNAIN阿里·沙哈，通讯作者的联系信息，电子邮件通讯作者，
    扎希德Azamb ，
    Javeria Raufa ，
    流星阿比达，
    赛义德·哈米达，
    瓦西姆Jafria ，
    阿卜杜拉Khalidb ，
    费萨尔伊斯梅拉，
    嗡Parkasha ，
    AMNA Subhana ，
    赛义德·穆罕默德· Munirc

    消化内科，阿迦汗大学，卡拉奇，巴基斯坦的第
    肝和胃肠疾病健康科学陶氏B大学国家研究所，卡拉奇，巴基斯坦
    C医疗单位七，真纳研究生医学中心，卡拉奇，巴基斯坦


摘要
背景和目的

食管静脉曲张破裂出血是肝硬化患者的主要问题。内窥镜静脉曲张结扎（ EVL ）已被证明是等于或大于普萘洛尔在防止第一泄放更好。卡维地洛是一种非选择性β-阻断剂与α- 1肾上腺素能受体阻断剂的活性。血液动力学研究表明，卡维地洛比普萘洛尔更有效地降低门静脉压力。我们比较卡维地洛的疗效与EVL对食管静脉曲张破裂出血一级预防。
方法

肝硬化食管静脉曲张患者被随机分为卡维地洛12.5毫克每日或EVL在巴基斯坦的三所大学医院。终点是食管静脉曲张破裂出血，死亡或肝移植。
结果

209名患者进行了评价。分别为82例和86例患者随机分为卡维地洛和EVL武器。平均年龄为48 ±12.2岁; 122 （ 72.7 ％ ）为男性， 89.9 ％为病毒性肝硬化，平均Child-Pugh评分为7.3 ± 1.6 ，平均随访was13.3 ±12.1个月（范围1-50个月） 。既EVL和卡维地洛组有可比性静脉曲张破裂出血率（ 8.5 ％比6.9 ％ ） ，分别为出血相关死亡率（ 4.6 ​​％对4.9 ％）和总死亡率（ 12.8 ％对19.5 ％ ） 。卡维地洛组的不良反应为低血压（N = 2 ） ，要求停止治疗，而短暂的恶心（18例）和呼吸困难（ 30例）解决油然而生。在EVL手臂，绑扎后溃疡出血（N = 1），胸痛（ N = 17 ） ，被称为严重不良eventswhile短暂的吞咽困难（58例），而不处理解决。
结论

虽然我们的研究是动力不足，研究结果表明，卡维地洛可能并不优于EVL在预防首次静脉曲张出血患者的病毒性肝硬化。
缩略语

    EVL ，食管曲张静脉套扎术;
    EVB ，食管静脉曲张破裂出血;
    丙型肝炎病毒，丙型肝炎病毒;
    乙肝病毒，乙肝病毒;
    HDV ，丁型肝炎病毒;
    PVT ，门静脉血栓形成;
    肝癌，肝癌;
    GCP ，良好的临床实践;
    E.R ，急诊室;
    GV ，胃静脉曲张;
    电动车，食管静脉曲张;
    心电图，心电图;
    BCU ，出血监护室;
    血红蛋白，血红蛋白;
    ITT ，意向治疗;
    CI ，置信区间;
    缺血性心脏病，缺血性心脏疾病;
    HVPG ，肝静脉压力梯度;
    EGD ，食管 - 胃 - 十二指肠镜;
    TIPS ，经颈静脉肝内门体分流术;
    PSE ，波尔图，全身性脑病